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Table of Contents

FOREWORD

5

1. INTRODUCTION TO IEC 601

5

LOCAL ADAPTATION

6

COMMONLY USED DEFINITIONS WITHIN IEC 60601

6

SYMBOLS AND MARKINGS

8

2. VISUAL INSPECTION

9

2. EARTH BOND TESTING

9

4. LEAKAGE MEASUREMENTS

10

IEC 601 BODY MODEL

12

SINGLE FAULT CONDITION

12

EARTH LEAKAGE TEST

13

ENCLOSURE LEAKAGE TEST

14

PATIENT LEAKAGE

15

PATIENT LEAKAGE – F-TYPE

16

PATIENT AUXILIARY CURRENT

17

5. RECORD KEEPING

18

6. CONCLUSION

18

ANNEX A - IEC 60601-1 TEST LIMITS

19

ANNEX B - IEC60601-1 BODY MODEL

19

ANNEX C - PATIENT ENVIRONMENT

20

ANNEX D - IEC 60601 TEST STANDARDS

21

05

Foreword

This booklet is written as a guideline for people involved in testing medical electrical equipment and cannot

be considered to replace the IEC 60601 standard.

All reasonable care has been taken to ensure accuracy of the information. Reference figures and data have

been taken from the latest versions of various standards, guidance notes and recognised ‘best practices’ to

establish the recommended testing requirements,

Rigel Medical, their agents and distributors, accept no responsibility for any error or omissions within this

booklet, or for any misinterpretations by the user. For clarification on any part of this booklet please

contact Rigel Medical before operating any test instrument, under relevant legislation.

No part of this publication shall be deemed to form, or be part of any contract for training or equipment

unless specifically referred to as an inclusion within such contract.

Rigel Medical assumes, that the readers of this booklet are electronic technical competent and therefore

does not accept any liability arising from accidents or fatalities resulting directly or indirectly from the tests

described in this booklet.

1. Introduction to IEC 60601

It can be assumed that not all people will understand the dangers associated with the exposure to electricity.

It is this danger that has triggered several discussions relating to the safety of all members of the public.

Regulatory bodies world-wide have acknowledged the dangers of electricity by producing legislation,

standards and/or guidelines to control the design of electrical appliances in order to prevent any hazard to

the general public.

One environment where electric currents pose an acute threat is in the medical treatment and care of

patients. Often, patients are physically connected to one or more electrical medical devices for a period of

time. In these circumstances it is possible that patients are unaware of being exposed to electrical currents,

especially if patients are treated under full or local anaesthetic. During invasive treatments, the human

body's natural protection organ, the skin, no longer provides the basic insulation against electrical currents.

It is during these treatments that electrical currents as low as 50mA can float through the human body and

cause the heart to fibrillate or paralyse the respiratory system.

To govern the design of medical equipment, the International Electrotechnical Committee, the IEC has

produced a standard to control all aspects of safety directly or indirectly relating to the handling, use or

connection to, of medical equipment. This standard is referenced to as IEC 60601, or by many simply referred

to as IEC 601.

The IEC60601 was first published in 1977 (then referred to as IEC 601) and handles the electrical safety of both

mechanical and electrical issues and is constructed from 2 parts; IEC 60601-1 and IEC 60601-2, each build-up

from a number of basic or collateral standards.

IEC 60601-1-X (X representing a specific standard number between 1-4) is the primary standard and has four

(sub) standards directly relating to the safety of medical equipment.

IEC 60601-2-X (X representing a specific standard number between 1-50). This part of the standard is specific

to various types of medical equipment and provides additional information to the four basic standards.

Annex D provides an overview of the IEC 60101-1-X and IEC 60601-2-X standards.

This booklet describes the electrical safety requirements for compliances with IEC 60601-1. Although a type

test standard, most of these tests are used for regular testing or after service or repair of medical devices.

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Local Adaptation

In many cases the IEC 60601 standard has been adapted into local standards for use in

countries around the world. Some examples are EN 60601 (EC), UL2601-1 (USA), CSA C22.2

(Canada) and AS/NZ 3200-1 (Australia / New Zealand).

Clearly, safety testing at the design stage and at the end of the production line are vitally

important, but what about when the equipment enters service? Pending a recognised

international standard for in-service testing, a number of countries have introduced their

own national test recommendations.

Some countries have gone one step further and produced standards or guidelines for

safety testing of newly delivered medical devices (also referred to as acceptance test),

testing during regular intervals, (also referred to as preventive maintenance), or directly

following service or repair. Some examples are MDA DB9801 (UK), VDE 750/751 (Germany),

AS/NZ 3551 (Australia / New Zealand), NFPA / AAMI (USA)

Countries without a national guidance or code of practice mainly follow the

manufacturers instructions or guideline, which most likely refer to the IEC 60601-1 test

requirements and limits to be repeated. In essence all standards have one thing in common

and that is to control the safety of medical devices for use in the treatment, care and

diagnosis of patients and/or individuals.

Commonly used definitions

within IEC 60601

Equipment Under Test

The equipment (EUT) which is the subject of testing.

Device Under Test

The device (DUT) which is the subject of testing.

Applied Part

Part of the medical equipment, which is designed to

come into physical contact with the patient, or parts

that are likely to be brought into contact with the patient.

Patient Connection

Individual physical connections and / or metal parts

intended for connection with the patient, which

form (part of) an Applied Part.

07

Patient Environment

Volumetric area in which a patient can come into contact with

medical equipment or contact can occur between other persons

touching medical equipment and the patient, both intentional

and unintentional. (

see Annex C)

F-Type Applied Part

Applied Part which is electrically isolated from Earth and other parts

of the medical equipment. i.e. floating. F-type applied parts are either

type BF or type CF applied parts.

Type B Applied Part

Applied Part complying with specified requirements for protection against

electric shock. Type B Applied Parts are those parts, which are usually

Earth referenced. Type B are those parts not suitable for direct

cardiac application.

Type BF Applied Part

F-Type Applied Part complying with a higher degree of protection against

electric shock than Type B Applied Parts. Type BF Applied Parts are those

parts not suitable for direct cardiac application.

Type CF Applied Part

F-Type Applied Part complying with the highest degree of protection

against electric shock. Type CF Applied Parts are those parts suitable

for direct cardiac application.

Medical Electrical

Electrical equipment, designed for treatment, monitoring or

Equipment

diagnoses of patients, powered from not more than one connection to

mains supply and which are necessarily in physical or electrical contact

with the patient or transfers energy to or from the patient or detects such

energy transfer to or from the patient.

Medical Electrical

Combination of equipment of which at least one is classed as medical

System

electrical equipment and as such specified by the manufacturer

to be connected by functional connection or use of a multiple portable

socket-outlet.

Class I (Earthed)

Equipment protection against electric shock by additional

protection to basic insulation through means of connecting

exposed conductive parts to the protective earth in the fixed

wiring of the installation.

Class II

Also referred to as Double Insulated. Equipment protection against

electric shock by additional protection to basic insulation through

means of supplementary insulation are provided, there being no

provision for the connection of exposed metalwork of the equipment

to a protective conductor and no reliance upon precautions to be taken

in the fixed wiring of the installation.

NOTE

CLASS II EQUIPMENT may be provided with a FUNCTIONAL

EARTH TERMINAL or a FUNCTIONAL EARTH CONDUCTOR.

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Symbols and Markings

The IEC 60601 has defined the requirements for information / data to be present

on the medical equipment's nameplate, in order to form an unambiguous

identification of the equipment.

Information must include: manufacturers name, model number, serial number,

electrical requirements etc.

The IEC 60601 standard refers to a large variety of symbols for use on medical

equipment, medical systems, accessories and other related parts. A full overview

of the symbols used in IEC 60601 is provided in the standard.

For the purpose of this booklet, a selection of the most commonly used symbols

are displayed below:

Class I

Earth

Reference

point

Class II

i.e.

“Conformité

Européenne”

Type B

Applied Part

Defibrillation

proof type B

Applied Part

Type BF

Applied Part

Defibrillation

proof type BF

Applied Part

Type CF

Applied Part

Defibrillation

proof type CF

Applied Part

09

2. Visual Inspection

The process of visual inspection is not clearly defined by IEC 60601, however visual

inspections form a critical part of the general safety inspections during the functional life

of medical equipment. Upto, 70% of all faults are detected during visual inspection.

Visual inspection is a relatively easy procedure to make sure that the medical equipment in

use is still conform the specifications as released by the manufacturer and has not suffered

from any external damage and or contamination.

These can include the following inspections:

•

Housing / Enclosure;

Look for damage, cracks etc

•

Cabling (supply, applied parts etc);

Look for cuts, wrong connections etc

•

Fuse Rating;

Check correct values after replacement

•

Markings and Labelling;

Check the integrity

•

Integrity of Mechanical Parts;

Check for any obstructions

3. Earthbond Testing

Earthbond Testing, also referred to as Groundbond Testing, tests the integrity of the

low resistance connection between the earth conductor and any metal conductive

parts, which may become live in case of a fault on Class I medical devices. Although

many Class I medical devices are supplied with an earth reference point, most if not

all medical devices require multiple earthbond tests to validate the connections of

additional metal accessible parts on the enclosure.

The test current is applied between the earth pin of the mains supply plug and any

accessible metal part (including earth reference point) via a dedicated earth bond test

lead (clip/probe).

The IEC 60601-1 (clause 8.6.4) requires a minimum test current of 25 Ampere AC or 1.5

times the highest rated current of the relevant circuit(s) which ever is greater. The

open circuit voltage of the current source should not exceed 6V.

A test current of 25 Ampere AC is most commonly used. Due to the exposure of high

current, some (parts of the) equipment could be damaged and thus requiring a lower

test current. However, the earthbond test is designed to stress the connection under

fault conditions.

Faults in the detachable power cord account for 80-90% of all earthbond failures, as

most moulded power cables are prone to stress when the cables are dropped.

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For fixed installations (ie MRI or X-RAY equipment) a Point-to-Point continuity

measurement can be made. The resistance is then measured between two probes,

where one would be connected to the incoming earth reference point and one probe

is placed on metal accessible parts of the medical installation.

Test limits are set at 0.1 Ohm for fixed power cords and 0.2 Ohm for equipment with a

detachable power cord. See

Annex A for a full overview of the IEC 60601-1 test limits.

Prolonged use of testing at high currents can lead to a high probe temperature. Care

should be taken to avoid touching the probe tip under these conditions.

4. Leakage Measurements

Research has shown that current not voltage is often the source of injury or death. It

takes only a small amount of current to cause major consequences.

When an electrical current flows through the human body the effect is influenced by

two main factors, firstly the amount of current and secondly the length of time the

current flows.

For example; the heart stops if the current persists for:

a) 250mS at 40mA

b) 100mS at 100mA

c) 50mS

at 200mA

Consider the following examples of the effect of current on the human body when

applied to the skin (non invasive);

0.9

-----1.2mA

Current just perceptible

15.0 -----20.0mA

Release impossible: cannot be tolerated over 15 minutes

50.0 -----100.0mA Ventricular fibrillation, respiratory arrest,

leading directly to death

100.0 -----200.0mA Serious burns and muscular contraction of such a degree

that the thoracic muscles constrict the heart

Compare these values to the fact that 250mA of current is required to power a 25

watt lamp

For this reason, the IEC 60601 committee has set stringent rules on the design of

medical equipment as to prevent any patient or operator being exposed to currents

not part of the functional operation of the device. These currents are referred to as

leakage currents.

11

IEC 60601-1 requires that leakage current measurements of medical devices are performed when

the equipment is powered from an earth referenced supply (through isolation transformer), with

an output voltage of 110% of the rated supply voltage. The medical device must be in full

operational mode and at operational temperature if applicable. In many cases, isolation of

medical devices is only provided by active circuitry; hence true leakage values can ONLY be

measured ones the equipment is in full operation. Equipment that is not in full operation might

result in FALSE low leakage values.

IEC 60601 defines leakage current of three different sources.

•

Earth Leakage; current flowing down the protective earth

conductor of the mains inlet lead.

•

Enclosure Leakage; current flowing to earth through a person

by touching the medical equipment / system or part of.

•

Applied Part or Patient Leakage; current flowing through a person

to earth from the applied part or current flowing from a person

to earth via the applied part by applying unintended voltage

from an external source.

Applied Part / Patient Leakage can be classed into number of measurements such as:

•

Patient Leakage

(please refer to the corresponding paragraph)

•

Patient Auxiliary Leakage

(please refer to the corresponding paragraph)

•

Patient F-type Leakage

(please refer to the corresponding paragraph)

Applied Part or Patient Leakage is the most important part of the leakage measurement on any

medical device. Applied Parts are directly in contact with the patient and are in case of invasive

devices placed under the patient's skin, which forms our natural protection against electrical

currents. Currents applied under the skin can result in far greater consequences. Currents as low

as 15

µA can result in fatality.

The limits for leakage currents within the IEC 60601-1 requirements are set to minimizing the

probability of ventricular fibrillation to a factor as low as 0.002 (Limit of 10

µA for CF Applied

Part under normal condition). See

Annex A for a full overview of the IEC 60601-1 test limits.

The following tests find their origin from the IEC 60601-1 but are specific the AAMI and NFPA 99

standards (USA)

•

Patient Leakage - Applied Part to Ground.

Similar to Patient Leakage described above.

•

Patient Leakage - Applied Part to Case.

Similar to Patient Leakage except that the leakage current path is from

the applied parts, through the patient, to the case of the EUT/DUT.

•

Patient Auxiliary (Applied Part to Applied Part);

Similar to Patient Auxiliary current.

•

Patient Auxiliary (Applied Part to All);

Similar to Patient Auxiliary current.

For the purpose of this booklet, the focus will be on the directly related leakage measurements

as per IEC 60601-1.

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WARNING - Mains voltage applied to appliance

It is important to verify that a medical device with moving parts (e.g. motor or pump) is safely

mounted to allow movement without causing damage to equipment or personnel.

Secondary earth paths will effect the leakage measurements and might give false PASS readings.

Always make sure that the device under test is positioned safely and isolated from earth

when measuring leakage.

IEC 601 Body Model

To ensure a traceable simulation of current as if passing through a human body, measurement circuits

have been designed to simulate the average typical electrical characteristics of the human body.

These measurement circuits are referred to as Body Models or Measuring Device (MD in IEC 60601-1)

Some standards such as the AAMI / NFPA 99 and the IEC 61010 (electrical equipment for measurement,

control and Laboratory use) specify different electrical characteristics to that of the IEC 60601-1.

The IEC 60601-1 body model or measuring device is shown in

Annex B.

Single Fault Condition

To maintain a medical device’s high level of protection during it’s operational life, a number of design

features are taken into account to maintain the integrity of the device's electrical safety.

This is done by introducing conditions that could occur under normal use (ie reversed mains supply or

voltage on signal input/output terminals - SIP/SOP) and conditions that can occur under

a single fault condition (SFC).

IEC 60601-1 specifies a number of single fault conditions (SFC) under its clause 8.1. For the purpose of

this booklet, the only highlighted SFC are the interrupted earth connection (Open Earth) and

interruption of any of the supply conductors (Open Neutral).

IEC 60601-1 specifies that all leakage measurements should be carried out using normal and single fault

conditions. A typical part of the electrical safety testing procedures is to perform the test as follows:

1. Normal Supply Voltage

No (SFC)

2. Normal Supply Voltage

Open Neutral

3. Normal Supply Voltage

Open Earth

4. Reversed Supply Voltage

No (SFC)

5. Reversed Supply Voltage

Open Neutral

6. Reversed Supply Voltage

Open Earth

In addition to these test, some manufacturers might choose to include voltage on the signal input /

output terminals (ie communication ports such as USB or RS 232). As this test can be destructive,

it is not commonly used other than during type testing of the medical electrical equipment.

13

Earth Leakage Test

The Earth Leakage Test shows the current flowing through or via the insulation of the medical

device into the protective earth conductor. The earth leakage test is important as it

demonstrates the total leakage from the EUT / DUT.

IEC 60601-1 specifies that the measurements are done under normal and reverse operation and

single fault condition (neutral open circuit). The earth leakage test is valid for Class I

equipment with Types B, BF and CF applied parts.

Annex A shows the pass/fail limits as per IEC

60601-1 requirements.

Note - SFC 'Open Earth’ cannot be performed as this would result in zero leakage

measurements under all circumstances.

Diagram A shows a schematic interpretation of the earth leakage measurement including the

relays operating the single fault conditions.

Earth Leakage, normal conditions - This test measures the earth leakage current under normal

conditions. The current is measured through the Measuring Device with S1 closed and S5

normal and then S5 reversed.

Earth Leakage, single fault, supply open - This test measures the earth leakage current with a

single fault condition (supply open). The current is measured through the Measuring Device

with S1 open and S5 normal and then S5 reversed.

S5

S1

Equipment
UnderTest

Protective
Earth

Applied
Part

Mains
Part

Measuring
Device

Diagram A - Test Circuit For Earth Leakage

Mains

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Enclosure Leakage Test

In general, Enclosure Leakage displays the current that would flow if a person would come in

contact with the housing (or any accessible part not intended for treatment or care) of the

medical device.

IEC 60601-1 specifies that the measurements are done under normal and reverse operation of

the mains supply and single fault conditions Open Neutral circuit and Open Earth. The

Enclosure Leakage Test is valid for both Class 1 and II equipment with Types B, BF and CF

Applied Parts.

Annex A shows the pass/fail limits as per IEC 60601-1 requirements.

Note - for Class II equipment, the Single Fault Earth Open tests are not required.

In the case of Class II devices, or fully insulated enclosures, this can be encapsulated by using

aluminium foil of approximately 200 cm

2

. The enclosure leakage is measured by connecting the

aluminium foil to the leakage tester.

Diagram B shows a schematic interpretation of the earth leakage measurement including the

relays operating the single fault conditions.

Enclosure Leakage, normal condition - This test measures the enclosure leakage current

under normal conditions. The current is measured through the Measuring Device with S1 and

S8 closed and S5 normal and reversed.

Enclosure Leakage, single fault, supply open - This test measures the enclosure leakage

current with a single fault condition (supply open). The current is measured through the

Measuring Device with S1 open, S8 closed and S5 in normal and then S5 reversed.

Enclosure Leakage, single fault, earth open -This test measures the enclosure leakage

current with a single fault condition (earth open). The current is measured through the

Measuring Device with S1 closed, S8 open and S5 in normal and then S5 reversed.

S5

S1

Equipment
UnderTest

Protective
Earth

Applied
Part

Mains
Part

Diagram B - Test Circuit For Enclosure Leakage

Mains

S8

Measuring
Device

S5

S1

Equipment
UnderTest

Protective
Earth

Applied
Part

Mains
Part

Diagram B - Test Circuit For Enclosure Leakage

Mains

S8

Measuring
Device

15

Patient Leakage

The Patient Leakage Current is the current flowing from the Applied Part via the patient to

earth or flowing from the patient via an Applied Part to earth, which originates from an

unintended voltage appearing on an external source.

IEC 60601-1 specifies that the measurements be done under normal and reverse operation of

the mains supply and single fault conditions Open Neutral circuit and Open Earth. The Patient

Leakage Test is valid for both Class 1 and II equipment with Types B, BF and CF applied.

Annex A shows the pass/fail limits as per IEC 60601-1 requirements.

Note For Class II equipment, the Single Fault Earth Open tests are not required.

For type CF equipment the patient leakage current is measured from each applied part

separately however, for type B and BF equipment, the patient leakage current is measured

with all applied parts connected together. Diagram C shows a schematic interpretation of the

Patient Leakage measurement including the relays operating the single fault conditions.

Patient Leakage, normal condition - This test measures the patient leakage current under

normal conditions. The current is measured through the Measuring Device with S1 and S8

closed, S5 normal and then S5 reversed.

Patient Leakage, single fault, supply open - This test measures the patient leakage current

with a single fault condition (supply open). The current is measured through the Measuring

Device with S1 open, S8 closed and S5 normal and then S5 reversed.

Patient Leakage, single fault, earth open - This test measures the patient leakage current

with a single fault condition (earth open). The current is measured through the Measuring

Device with S1 closed, S8 open and S5 normal and then S5 reversed.

S5

S1

Equipment
UnderTest

Protective
Earth

Applied
Part

Mains
Part

Measuring
Device

Diagram C - Test Circuit For Patient Leakage Current

Mains

S8

S5

S1

Equipment
UnderTest

Protective
Earth

Applied
Part

Mains
Part

Measuring
Device

Diagram C - Test Circuit For Patient Leakage Current

Mains

S8

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Patient Leakage – F-Type

The Patient Leakage F-Type Test (also known as mains on Applied Parts test) displays the current

that would flow if a mains potential was applied to the Applied Part which was attached to a

patient (i.e. a single fault condition). This test is applied only to type BF and CF equipment.

This test involves applying a current limited mains potential (110% of mains input voltage) to the

Applied Parts connections. Due to the requirements for IEC 60601-1 this test current can be in

excess of 5mA under short circuit conditions and as such is hazardous to the user. Caution

should be taken when conducting this test. Current limiting is via a limiting resistor in series

with the measurement circuit.

IEC60601-1 specifies that leakage current for type CF Applied Parts is measured from each of the

patient connection / applied parts separately. For type BF equipment the leakage current is

measured with all parts of the same type applied parts connected together, shown dotted below.

The F-type Leakage test is valid for both Class 1 and II equipment and are measured under mains

normal or reverse and source voltage normal or reverse conditions.

Annex A shows the pass/fail

limits as per IEC 60601-1 requirements.

Diagram D shows a schematic interpretation of the F-Type Leakage measurement including the

relays operating the single fault conditions.

The current is measured through the Measuring Device with S1 and S8 closed. S5 and S9 are

switched between normal and reversed.

S5

S1

Equipment
UnderTest

Protective
Earth

Applied
Part

Mains
Part

Diagram D - Test Circuit For Patient Leakage Current, Mains On Applied Part

Mains

S8

Measuring
Device

Mains

S9

R

S5

S1

Equipment
UnderTest

Protective
Earth

Applied
Part

Mains
Part

Diagram D - Test Circuit For Patient Leakage Current, Mains On Applied Part

Mains

S8

Measuring
Device

Mains

S9

R

17

Patient Auxiliary Current

The Patient Auxiliary Current displays the leakage current that would flow between Applied Parts

under normal and fault conditions. For these tests, current is measured between a single part of the

applied part and all other applied parts connected together. This test should be repeated until all

combinations have been tested. This is also referred to as Applied Part to All.

IEC 60601-1 specifies that the measurements be carried out under normal and reverse operation of

the mains supply and single fault conditions Open Neutral circuit and Open Earth. The Patient

Auxiliary Leakage test is valid for both Class 1 and II equipment with Types B, BF and CF applied.

Note For Class II equipment, the Single Fault Earth Open tests are not required.

Diagram E shows a schematic interpretation of the Patient Auxiliary Leakage measurement

including the relays operating the single fault conditions.

Patient Auxiliary, normal condition - This test measures the patient auxiliary current under

normal conditions. The current is measured through the Measuring Device with S1 and S8 closed, S5

normal and then S5 reversed.

Patient Auxiliary, single fault, supply open - This test measures the patient auxiliary current

under a single fault condition (supply open). The current is measured through the Measuring Device

with S1 open, S8 closed and S5 normal and then S5 reversed.

Patient Auxiliary, single fault, earth open - This test measures the patient auxiliary current under

a single fault condition (earth open). The current is measured through the Measuring Device with S1

closed, S8 open and S5 normal and then S5 reversed.

Equipment
UnderTest

Protective
Earth

Diagram E - Test Circuit For Patient Auxilary Current

S5

S1

Mains

S8

Measuring
Device

Applied
Part

Mains
Part

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5. Record Keeping

Currently, manual paper-based systems provide the main method of recording safety testing results

in most hospitals. However, as asset management systems gain more favour as a means of tracking

equipment, PC-based test records are likely to become more popular in the future. Such systems will

enable historical database records to be established to assist in the formulation of preventative

maintenance programmes and also contribute to risk assessment calculations.

Test instrument manufacturers, who have already responded with the introduction of instruments

capable of storing test results for subsequent downloading to printers, are therefore likely to

develop new testers with PC compatible software programmes for records keeping purposes.

Overall, the area of risk assessment and the creation of risk management files has become a growing

feature of routine safety testing decisions, with different organisations and departments drawing-up

individual plans to deal with specific safety hazards.

For the future, therefore, determining the appropriate levels of electrical testing to be taken

without compromising the safety of staff or patients will be central to the introduction of cost

effective yet reliable preventative maintenance campaigns.

6. Conclusion

Electrical safety testing of medical electronic devices remains a crucial part of the overall safety

validation of medical devices and requires specialised test equipment.

When choosing your electrical safety analyser make sure, firstly, that it can be used to test in

accordance with the IEC 60601-1 requirements, and secondly that your analyser will enable you to

accurately and repeatedly produce the results you require.

Essential requirements for electrical safety analysers are:

•

User safety (never compromise)

•

25Ampere AC earth bond (ground bond) testing up to loads exceeding 0.2 Ohm

•

Measuring device meets the frequency response of the IEC 60601-1 body model

•

High accuracy and repeatability of leakage measurement readings (Some

manufacturers might specify accuracy of full scale reading which will effect the

accuracy of low leakage measurements)

•

Traceability of measurement results (Do you require data storage?)

•

Test convenience (test duration, user interface, can you save time?) and reduce

risk of misinterpretation.

Rigel Medical offers a range of test equipment in line with the IEC 60601 requirements.

Please visit our website www.rigelmedical.com for a full overview of our product offering or register

online for our free newsletter on future product releases and product innovations.

For further questions or comments relating to this booklet or on the Rigel Medical product offering,

please contact John Backes via email at [e-mail]

19

Annex A - IEC 60601-1 Test Limits

Annex B - IEC 60601 Body Model

Example of a measuring device MD according to IEC 60601-1 and its frequency characteristics

Leakage Current Type

NC

SFC

NC

SFC

NC

SFC

Earth Leakage (General)

0.5mA

1mA

0.5mA

1mA

0.5mA

1mA

Enclosure Leakage

0.1mA

0.5mA

0.1mA

0.5mA

0.1mA

0.5mA

Patient Leakage (dc)

0.01mA

0.05mA

0.01mA

0.05mA

0.01mA

0.05mA

Patient Leakage (ac)

0.1mA

0.5mA

0.1mA

0.5mA

0.01mA

0.05mA

Patient Leakage (F-Type)

NA

NA

NA

5mA

NA

0.05mA

Patient Leakage

(Mains on SIP/SOP)

NA

5mA

NA

NA

NA

NA

Patient Auxiliary Current (dc)

0.01mA

0.05mA

0.01mA

0.05mA

0.01mA

0.05mA

Patient Auxiliary Current (ac)

0.1mA

0.5mA

0.1mA

0.5mA

0.01mA

0.05mA

Type B

Applied Parts

Type BF

Applied Parts

Type CF

Applied Parts

Non Detachable power cord

< 0.1

Ω

Detachable power cord

< 0.2

Ω

Earthbond test limit at 25A, 50Hz

R

1

R

2

C

1

Z

Voltage

measuring

instrument

b)

R

1

R

2

C

1

= 10 k

Ω±5%

a)

= 1 k

Ω±5%

a)

= 0,015

µF±5%

a) Measuring device

b) Frequency characteristics

Frequency(

ƒ) in Hz

R

e

la

t

iv

e

m

a

g

n

it

u

d

e

c

)

(d

b

):

2

0

lo

g

Z

(ƒ

)

Z

(ƒ

=

1

0

)

+20

0

-20

-40

-60

10

10

2

10

3

10

4

10

5

10

6

v

NOTE

The network and voltage measuring instrument above are replaced by the symbol in the following figures

MD

Non inductive components

Impedance >> measuring impedance Z

Z(

ƒ) is the transfer impedance of the network, i.e. V

out/in

, for a current frequency

ƒ.

a)

b)

c)

Annex C - Patient Environment

A PRA

CTICAL GUIDE T

O

IEC601

1.5m

1.5m

2.5m

1

1

1.

5m

IEC 60601-1-1

MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR SAFETY 1: COLLATERAL STANDARD:

SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

IEC 60601-1-2

MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR SAFETY 2. COLLATERAL STANDARD:

ELECTROMAGNETIC COMPATIBILITY –REQUIREMENTS AND TESTS

IEC 60601-1-3

MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR SAFETY – COLLATERAL STANDARD:

GENERAL REQUIREMENTS FOR RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT

IEC 60601-1-4

MEDICAL ELECTRICAL EQUIPMENT: PART 1-4: GENERAL REQUIREMENTS FOR COLLATERAL STANDARD:

PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS

Annex D - IEC 60601 Test Standards

Table 1 – IEC 60601 Collateral Standards

(© IEC Geneva, Switzerland)

IEC 60601-2-1

MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRON

ACCELERATORS IN THE RANGE 1 MeV TO 50 MeV

IEC 60601-2-2

MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH

FREQUENCY SURGICAL EQUIPMENT

IEC 60601-2-3

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF SHORT-WAVE

THERAPY EQUIPMENT

IEC 60601-2-4

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC

DEFIBRILLATORS AND CARDIAC DEFIBRILLATORS MONITORS

IEC 60601-2-5

MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ULTRASONIC

PHYSIOTHERAPY EQUIPMENT

IEC 60601-2-6

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF MICROWAVE

THERAPY EQUIPMENT

IEC 60601-2-7

MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE

GENERATORS OF DIAGNOSTIC X-RAY GENERATORS

IEC 60601-2-8

MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR THE SAFETY OF THERAPEUTIC

X-RAY EQUIPMENT OPERATING IN THE RANGE 10 kV TO 1 MV

IEC 60601-2-9

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF PATIENT

CONTACT DOSEMETERS USED IN RADIOTHERAPY WITHELECTRICALLY CONNECTED RADIATION DETECTORS

IEC 60601-2-10

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF NERVE AND

MUSCLE STIMULATORS

IEC 60601-2-12

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF GAMMA BEAM

THERAPHY EQUIPMENT

IEC 60601-2-11

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF LUNG

VENTILATORS FOR MEDICAL USE

IEC 60601-2-13

MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC

WORKSTATIONS

IEC 60601-2-14

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF

ELECTROCONVULSIVE THERAPY EQUIPMENT

IEC 60601-2-15

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF CAPACITOR

DISCHARGE X-RAY GENERATORS

IEC 60601-2-16

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF HAEMODIALYSIS

EQUIPMENT

IEC 60601-2-17

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF

REMOTE- CONTROLLED AUTOMATICALLY DRIVEN GAMMARAY AFTER-LOADING EQUIPMENT

IEC 60601-2-18

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ENDOSCOPIC

EQUIPMENT

IEC 60601-2-19

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS OF SAFETY OF BABY INCUBATORS

IEC 60601-2-20

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF TRANSPORT

INCUBATORS

IEC 60601-2-21

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFANT RADIANT

WARMERS

Table 2 – IEC 60601 Specific Standards

(© IEC Geneva, Switzerland)

21

IEC 60601-2-22

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF DIAGNOSTIC AND

THERAPEUTIC LASER EQUIPMENT

IEC 60601-2-23

MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING

ESSENTIAL PERFORMANCE, OF TRANSCUTANEOUSPARTIAL PRESSURE MONITORING EQUIPMENT

IEC 60601-2-24

MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARITCULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS

AND CONTROLLERS

IEC 60601-2-25

MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE SAFETY OF

ELECTROCARDIOGRAPHS

IEC 60601-2-26

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF

ELECTROENCEPHALOGRAPHS

IEC 60601-2-27

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF

ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT

IEC 60601-2-28

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY SOURCE

ASSEMBLIES AND X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS

IEC 60601-2-29

MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPHY

SIMULATORS

IEC 60601-2-30

MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING

ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT

IEC 60601-2-31

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF EXTERNAL CARDIAC

PACEMAKERS WITH INTERNAL POWER SOURCE

IEC 60601-2-32

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED

EQUIPMENT OF X-RAY EQUIPMENT

IEC 60601-2-33

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF MAGNETIC

RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS

IEC 60601-2-34

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL

PERFORMANCE, OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT

IEC 60601-2-35

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF BLANKETS, PADS AND

MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE

IEC 60601-2-36

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF EQUIPMENT FOR

EXTRACORPOREALLY INDUCED LITHOTRIPSY

IEC 60601-2-38

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF ELECTRICALLY

OPERATED HOSPITAL BEDS

IEC 60601-2-39

MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PERITONEAL

DIALYSIS EQUIPMENT

IEC 60601-2-40

MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF

ELETROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT

IEC 60601-2-41

MEDICAL ELECTRICAL EQUIPMENT - PART 2-41: PARTICULAR REQUIREMENTS FOR THE SAFETY OF SURGICAL

LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS

IEC 60601-2-43

MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT

FOR INTERVENTIONAL PROCEDURES

IEC 60601-2-44

MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT

FOR COMPUTED TOMOGRAPHY

IEC 60601-2-45

MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAMMOGRAPHIC

X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES

IEC 60601-2-46

MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE SAFETY OF OPERATING

TABLES

IEC 60601-2-50

MEDICAL ELECTRICAL EQUIPMENT - PART 2-5O: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFANT

PHOTOTHERAPY EQUIPMENT

A PRA

CTICAL GUIDE T

O

IEC601